Ultrasound Therapy; Complications Clinical Trial
— ITUSROfficial title:
Intrapartum Translabial Ultrasonography Reliability in Comparison With Traditional Digital Examination
In a present study vaginal examination of the fetal head station is compared with transperineal ultrasonography evaluation of fetal head station and the ability of ultrasonography evaluation in predicting the time and mode of delivery will be investigated.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | March 30, 2023 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - At or over 36 weeks pregnant women - Pregnant women at the active phase of the first stage of labor - Pregnant women at the second stage of labor Exclusion Criteria: - Breech presentation - Fetal anomaly - In utero ex fetus cases - Trial of labor after cesarean cases - Pregnant women at the latent phase of the first sage of labor |
Country | Name | City | State |
---|---|---|---|
Turkey | Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital |
Turkey,
Akmal S, Kametas N, Tsoi E, Hargreaves C, Nicolaides KH. Comparison of transvaginal digital examination with intrapartum sonography to determine fetal head position before instrumental delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):437-40. doi: 10.1002/uog.103. — View Citation
Ciaciura-Jarno M, Cnota W, Wojtowicz D, Niesluchowska-Hoxha A, Ruci A, Kierach R, Stepien A, Nowak A, Sodowska P. Evaluation of selected ultrasonography parameters in the second stage of labor in prediction mode of delivery. Ginekol Pol. 2016;87(6):448-53. doi: 10.5603/GP.2016.0024. — View Citation
Dupuis O, Silveira R, Zentner A, Dittmar A, Gaucherand P, Cucherat M, Redarce T, Rudigoz RC. Birth simulator: reliability of transvaginal assessment of fetal head station as defined by the American College of Obstetricians and Gynecologists classification. Am J Obstet Gynecol. 2005 Mar;192(3):868-74. doi: 10.1016/j.ajog.2004.09.028. — View Citation
Iversen JK, Jacobsen AF, Mikkelsen TF, Eggebo TM. Structured clinical examinations in labor: rekindling the craft of obstetrics. J Matern Fetal Neonatal Med. 2021 Jun;34(12):1963-1969. doi: 10.1080/14767058.2019.1651283. Epub 2019 Aug 19. — View Citation
Ramphul M, Ooi PV, Burke G, Kennelly MM, Said SA, Montgomery AA, Murphy DJ. Instrumental delivery and ultrasound : a multicentre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery. BJOG. 2014 Jul;121(8):1029-38. doi: 10.1111/1471-0528.12810. Epub 2014 Apr 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acuracy of the fetal head progression distance | Transperineal measurement of fetal head station will be compared with vaginal examination of fetal head descent and these two measurements correlated with delivery outcomes | At any time in active phase of first stage or second stage of labor | |
Secondary | Interobserver agreement between vaginal examination fetal head station | The examination of fetal head levels by two clinicians compared with eachother. | At any time in active phase of first stage or second stage of labor | |
Secondary | Interobserver agreement between ultrasonographic fetal head station measurement | The correlation between two clinicians in measuring ultrasonographic fetal head station. | At any time in active phase of first stage or second stage of labor |
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